# K140650: Hivox Electric Stimulator Otc Tens

- Pathway: 510(k) (Traditional)
- Applicant: Hivox Biotek, Inc.
- Decided: Jun 27, 2014 after 106 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940301 (1994). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112392: Hivox Biotek Inc., Hivox Biotek, Inc. (2012)

## Most influential descendants
- K242815: Pocket Tens (EP-300) (2024), 0 descendants of its own
- K160323: FlowKeepers (2017), 0 descendants of its own

## Indications for use
The Rapid Relief ™ Pennypad PP-904 is indicated for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg), and lower back due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K140650
Methodology: https://510kreport.com/methodology